Ich & indian

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Ich & indian

  1. 1. ICH & INDIANGCP PROTOCOL by RAHUL challarahul77@gmail.com
  2. 2. ICH INDIAN1. General information 1. General information2. Back ground information 2. Objectives & justification3. Trial objectives & purpose 3. Ethical consideration4. Trial design 4. Study design5. Selection & with drawl of 5. Inclusive, exclusive & with subjects drawl of subjects6. Treatment of subjects 6. Handling of product7. Assessment of efficacy 7. Assessment of efficacy8. Assessment of safety 8. Assessment of safety9. Statistics 9. Statistics10. Direct access to source 10. Data handling & data/doc management
  3. 3. 11. Quality control & 11. Quality control & assurance assurance12. Ethics 12. Finance & insurance13. Data handling & record 13. Publication policy keeping 14. evaluation14. Financing & insurance15. Publication policy16. supplements

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